Table 3.
Mean scores from study instruments and outcome measures in three study time-points
| Category | Baseline | 3-month follow-up | 4-month follow-up | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
Intervention (N-16) Mean (SD)/ N (%) |
Control (N = 19) Mean (SD)/ N (%) |
P-value1 |
Intervention (N-16) Mean (SD)/ N (%) |
Control (N = 19) Mean (SD)/ N (%) |
P-value2 |
Intervention (N-16) Mean (SD)/ N (%) |
Control (N = 19) Mean (SD)/ N (%) |
P-value2 | ||
| Days with headache (days) | 13.5 (6.1) | 12.4 (7.4) | 0.341 | 7.9 (4.3) | 13.6 (8.1) | 0.001* | 5.4 (2.8) | 13.2 (8) | < 0.001* | |
| Pain-relievers (number) | 13.6 (6.7) | 10 (5.2) | 0.080 | 6.4 (4.6) | 11.2 (6.9) | < 0.001* | 4.9 (3.1) | 11.4 (7.1) | < 0.001* | |
| Headache severity-VAS | 8.6 (1.4) | 8.9 (1.2) | 0.603 | 6.8 (1.6) | 8.8 (1.3) | < 0.001* | 6.1 (1.4) | 8.8 (1.3) | < 0.001* | |
| MIDAS-total score | 39.8 (19.4) | 34 (23.7) | 0.174 | 17.9 (15.9) | 36 (24.8) | < 0.001* | 16 (16.5) | 36.4 (25.1) | < 0.001* | |
| MIDAS-A | 39.4 (17.1) | 35.3 (19.6) | 0.517 | 22.4 (14.2) | 37.8 (22.2) | < 0.001* | 19.8 (13.6) | 39.4 (21.1) | < 0.001* | |
| MIDAS-B | 7.9 (1.6) | 8.2 (1.2) | 0.494 | 6.3 (1.4) | 8.2 (1) | < 0.001* | 5.8 (1.4) | 8.2 (1.1) | < 0.001* | |
| MIDAS category | No disability | 0 | 0 | 0.797 | 2 (12.5%) | 0 | 0.106 | 4 (25%) | 0 | 0.021* |
| Mild | 2 (12.5%) | 4 (21.1%) | 5 (31.3%) | 4 (21.1%) | 4 (25%) | 4 (21.1%) | ||||
| Moderate | 2 (12.5%) | 2 (10.5%) | 4 (25%) | 2 (10.5%) | 5 (31.3%) | 3 (15/8%) | ||||
| Severe | 12 (75%) | 13 (68.4%) | 5 (31.3%) | 13 (68.4%) | 3 (18.8%) | 12 (63.2%) | ||||
| HIT | 63.7 (5.5) | 65.6 (6.6) | 0.357 | 56.9 (6.9) | 62.4 (9.2) | 0.099 | 53.4 (6) | 63.7 (7.8) | < 0.001* | |
| HIT category | Not severe | 0 | 1 (5.3%) | 0.352 | 4 (25%) | 3 (15.8%) | 0.497 | 8 (50%) | 1 (5.3%) | 0.003* |
| Severe | 16 (100%) | 18 (94.7%) | 12 (75%) | 16 (84.2%) | 8 (50%) | 18 (94.7%) | ||||
| HADS-anxiety | 10.5 (4.5) | 10.5 (3.2) | 0.642 | 7.9 (4.3) | 10.6 (3.7) | 0.002* | 6.8 (3.6) | 11.1 (3) | < 0.001* | |
| HADS-anxiety category | Normal | 4 (25%) | 4 (21.1%) | 0.959 | 10 (62.5%) | 6 (31.6%) | 0.092 | 10 (62.5%) | 3 (15.8%) | 0.013* |
| Borderline | 5 (31.3%) | 6 (31.6%) | 0 | 3 (15.8%) | 3 (18.8%) | 5 (26.3%) | ||||
| Abnormal | 7 (43.8%) | 9 (47.4%) | 6 (37.5%) | 10 (52.6%) | 3 (18.8%) | 11 (57.9%) | ||||
| HADS-depression | 9.8 (3.5) | 10.3 (3.7) | 0.684 | 7.8 (2.8) | 10.6 (2.9) | < 0.001* | 7.5 (2.1) | 11.2 (3.2) | < 0.001* | |
| HADS-depression category | Normal | 5 (31.3%) | 6 (31.6%) | 0.511 | 10 (62.5%) | 3 (15.8%) | 0.017* | 9 (56.3%) | 3 (15.8%) | 0.011* |
| Borderline | 5 (31.3%) | 3 (15.8%) | 3 (18.8%) | 8 (42.1%) | 5 (31.3%) | 5 (26.3%) | ||||
| Abnormal | 6 (37.5%) | 10 (52.6%) | 3 (18.8%) | 8 (42.1%) | 2 (12.5%) | 11 (57.9%) | ||||
| Emergency department visits for headache per month (number of cases) | 2 (12.5%) | 3 (15.8%) | 0.782 | 1 (6.3%) | 1 (5.3%) | 0.900 | 0 | 1 (5.3%) | 0.352 | |
VAS Visual Analog Scale, MIDAS Migraine Disability Assessment Scale, HIT Headache Impact Test, HADS Hospital Anxiety and Depression Scale, Days Number of days the patients have experienced headache within the past 30 days, Pain relievers Number of pain-relievers taken during the past 30 days
1Between group comparison. P-value calculated using Chi-square test (for categorical variables) or independent t-test (for interval variables) as appropriate
2Between group comparison. P-value calculated using Chi-square test (for categorical variables) or one-way analysis of covariance (for interval variables) after adjusting for baseline scores
*Indicating statistically significant p—values